Status:
UNKNOWN
Study of the Application of Magnetic Fields for the Treatment of Parkinson's Disease
Lead Sponsor:
pico-tesla Magnetic Therapies, LLC
Conditions:
Parkinson's Disease
Quality of Life
Eligibility:
All Genders
30-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to see if a device called the Resonator can help to improve aspects of health and quality of life that are relevant to patients with Parkinson's disease.
Detailed Description
This clinical trial will evaluate a new non-invasive, non-significant risk, device therapy as an adjuvant symptomatic treatment for some of the signs and or symptoms of Parkinson's Disease (PD). The d...
Eligibility Criteria
Inclusion
- Idiopathic Parkinson's Disease
- Stable optimized anti-PD drugs for at least 4 weeks
- PDQ-39 Summary Index between 15 and 45
- Ambulatory
- Willing to maintain regular medication regime throughout study
- Able to abstain from starting in new treatments to improve PD symptoms during course of study.
- No prior surgical interventions for Parkinson's Disease
- Non-demented
- Minimum of 30 years of age, but not older than 85
- Capable of giving full written consent
Exclusion
- Atypical Parkinsonism such as progressive supranuclear palsy, multiple system atrophy, CBDG etc.
- Subjects may not have any of the following: active brain tumor, strokes, hydrocephalus, any other neurologic or non-neuro problem which may affect symptomatic expression of patients parkinsonism.
- Consumption of medications that can produce drug induced parkinsonism
- Chronic pain not associated with PD
- Current or past history of major psychiatric disturbance
- No typical or non-typical anti-psychotics for treatment of drug induced psychosis.
- Chronic fatigue
- Epilepsy or history of epilepsy
- Seizures or taking medication for epilepsy
- HIV or other autoimmune disorders
- History of ECT
- Uncontrolled hypertension
- Advanced pulmonary disease
- Unstable cardiac disease
- Prior surgical interventions for Parkinson's disease
- Prosthetics or implants comprised of ferrous metals
- Pacemaker, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain
- Pregnant, breast feeding or planning pregnancy prior to study end
- Dementia, developmental disability, psychiatric disorder or other cognitive impairment
- Any significant medical condition that may require alteration of medical therapy during the study, or major medical condition which may interfere with the study activity.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00863226
Start Date
March 1 2009
End Date
January 1 2012
Last Update
December 14 2011
Active Locations (6)
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1
University of Colorado Health Sciences Center
Aurora, Colorado, United States
2
Mile High Research Center
Denver, Colorado, United States, 80218
3
CNI Movement Disorders Center
Englewood, Colorado, United States, 80113
4
Suncoast Neuroscience Associates
Saint Petersbury, Florida, United States, 33713